The present invention relates to the method for handling calibrator or control samples in calibration and quality control for automatic analytical apparatus.
Such biological samples as serum, plasma and urine are analyzed by an automatic analytical apparatus. To ensure accurate analysis of many types of analysis items using a great number of samples, it is necessary to perform calibration using the calibrator samples in conformity to these analysis items, and to carry out quality control using the samples for quality control.
Official Gazette of Japanese Patent of Japanese Patent Laid-Open NO. 339732/1998 (TOKKAIHEI) discloses an automatic analytical apparatus with the analysis units laid out along the transfer line, where in the rack holding reference solutions and the rack holding control samples are transferred to the analysis unit to perform calibration and quality control. Calibration and quality control are repeated as required. U.S. Pat. No. 4,678,755 discloses an automatic analytical apparatus where calibration time intervals differ according to the type of analysis items.
The object of the present invention is to provide a method for handling specific solutions to relieve operators of burdensome work of checking the remaining volume of specific solution such as calibrator or control samples, and to permit highly reliable analysis procedures to be followed.
The present invention uses a rack loaded with one or more bottles to store specific solutions used repeatedly for calibration or quality control. Such a bottle is referred to as a specific bottle, and the corresponding rack is called a specific rack. The specific rack is set on the rack supply unit of the automatic analytical apparatus equipped with an analysis unit for sample analysis. Identification information provided on the specific bottle on the specific rack is read. Based on this information, the number of permissible services for each analysis system is stored in the storage unit with regard to the specific solution in all the specific bottles on the specific rack.
The planned number of times that calibration or quality control is performed is identified for each analysis item by the controller according to the information of request made to the controller. Based on said planned number of times and the number of permissible services stored in the storage unit, the controller determines if specific solution on the specific rack is sufficient or not. If the controller has determined it as insufficient, the number of new specific bottles that must be added is displayed on the screen of the display unit to ensure that the number of said bottles is sufficient for the planned number of times. The rack where new bottles are added is transferred to a specified analysis unit from the rack supply unit, and calibration or quality control are carried out.
In a preferred embodiment, the number of permissible services provided by the remaining specific solution is displayed on the display unit for each specific bottle on the specific rack. The controller determines whether or not the specific bottle set on the rack supply unit is the first bottle not registered previously. Based on the result of this evaluation, the controller manages the term of validity subsequent to opening of the bottle, using a reference time point which is the time when the identification information on said first bottle has been read. The analysis unit where the specific rack is fed is selected through the screen designed to select a combination of the types of analysis items and analysis units.